ORAL TRANSMUCOSAL FENTANYL CITRATE FOR PREMEDICATION IN ADULTS

This study was designed to assess the efficacy of oral transmucosal fe ntanyl citrate (OTFC) for premedication in an adult population and to determine its effects on anxiety, sedation, gastric volume, and gastri c fluid acidity. The fentanyl citrate is incorporated in a lozenge mou nted on a handle (oralet). The effects of OTFC, placebo oralet, and no premedication were compared in a prospective, double-blind study on 9 0 adult ASA physical status I and II patients undergoing same-day admi ssion surgery. Patients were randomly assigned to one of three groups: OTFC group (n = 30), placebo group (n = 30), and control group (n = 3 0). Arterial blood pressure, heart rate, respiratory frequency, and ox ygen saturation determined by pulse oximetry were recorded before any premedication was given, and then every 10 min until the patient was t aken to the operating room. Baseline anxiety and sedation levels were assessed to ensure group similarity immediately before premedication w as given and at the more anxiety-provoking phase upon entering the ope rating room. Anxiety levels were rated using the Spielberger State-Tra it Anxiety Inventory short form and sedation levels were assessed with the Ramsay scale. Side effects, as reported by the patients, were als o recorded. Gastric contents were aspirated via an orogastric tube aft er induction of anesthesia and were measured for volume and pH. No sig nificant differences were found among the three groups in mean arteria l pressure, heart rate, or respiratory frequency. Initial oxygen satur ation levels in all groups decreased after 30 min but not less than 96 % except for one patient in the OTFC group, who decreased to 88%. On e ntering the operating room, the OTFC group demonstrated significantly higher levels of anxiolysis than the control group, but no significant differences were seen between the OTFC and the placebo groups or the placebo and control groups. Mean gastric volumes (OTFC, 29 mL; placebo , 26 mL; control, 24 mL) and pH (OTFC, 2.0; placebo, 1.8; control, 2.1 ) were similar in all groups. There were no significant differences am ong the groups in levels of sedation achieved. Mild dizziness or light -headedness was the most commonly reported side effect in 23% of the O TFC group. In the OTFC group, 71.4% liked the premedicant effect as co mpared to 46.4% of the placebo group. Most of the groups found the ora let method of premedicant delivery very acceptable. This study demonst rates that the OTFC oralet is an effective anxiolytic in adults. It ha s minimal side effects and is prepared in an acceptable format. There was no measurable increase in gastric contents or acidity in the orale t groups, compared to those patients who were given nothing by mouth.